Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-30 @ 8:29 PM
Study NCT ID:
NCT01184703
Status:
COMPLETED
Last Update Posted:
2010-09-06
First Post:
2010-08-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Glycemic Index Diet in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-02', 'studyFirstSubmitDate': '2010-08-17', 'studyFirstSubmitQcDate': '2010-08-18', 'lastUpdatePostDateStruct': {'date': '2010-09-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HbA1c', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'LDL-cholesterol', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 1', 'Glycemic Index Diet', 'HbA1c', 'Lipids'], 'conditions': ['Diabetes Mellitus, Type 1']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if a low glycemic index diet in comparison with a medium/high glycemic index diet improves the metabolic control in patients with type 1 diabetes.', 'detailedDescription': 'The glycemic index (GI) was introduced by Jenkins and co-workers in the early 1980s, and is a concept for ranking of carbohydrate foods based on their effect on postprandial glycaemia. A meta-analysis of randomised controlled trials of the effect of low GI diets in the management of diabetes showed a beneficial effect (i.e., a reduction in HbA1c) of low GI versus high GI foods. However, several critical points concerning the GI concept remain, for instance, how to apply it in practical every day life, how to calculate GI in mixed meals, how to find relevant low GI foods, how to ensure compliance to a low GI diet. The most important issue, however, is the fact that studies on the long-term effects of a low GI diet in type 1 diabetes are lacking. In this study, the critical issue of finding palatable low GI foods will be solved in close collaboration with the food industry. This may lead to the development of new commercial products with low GI, which is necessary if low GI diets are to be advocated for diabetics in the future.\n\nComparison(s): A low glycemic index diet, compared to a medium/normal glycemic index diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type I diabetes, durability \\>5 years\n* Age 20-65 years\n* Normal weight (BMI 19-26 kg/m2)\n* Diabetic treatment with mealtime and bedtime insulin.\n* HbA1c ≤10 %\n* Informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.\n* A known food intolerance of gluten, leguminous plants, nuts or almonds.\n* Pregnancy or breast-feeding.\n* Concurrent participation in another research study with metabolic effects.\n* Previously regular follow-up with a dietician at SDC during the last year.\n* Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.\n* Non acceptance of the study diet or food products that are recommended in the study.\n* Disability to read and understand the Danish language.\n* Unable to receive and/or store the test products.\n* Place of residence \\>1 hr drive from SDC.'}, 'identificationModule': {'nctId': 'NCT01184703', 'acronym': 'LGID1', 'briefTitle': 'Low Glycemic Index Diet in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'Effects of a Low Glycemic Index Diet on HbA1c and Lipids in Patients With Type I Diabetes', 'orgStudyIdInfo': {'id': 'GI-project_1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Low GI food', 'type': 'OTHER', 'description': 'Comparison of carbohydrates in diabetic patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-2820', 'city': 'Gentofte Municipality', 'country': 'Denmark', 'facility': 'Steno Diabetes Center', 'geoPoint': {'lat': 55.74903, 'lon': 12.54601}}], 'overallOfficials': [{'name': 'Margareta Bensow Bacos, Ch Diet', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Steno Diabetes Center Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Margareta Bensow Bacos', 'oldOrganization': 'Steno Diabetes Center'}}}}